Patients with hemilateral age-related macular degeneration (AMD)
Conditions
Interventions
The subjects are to take a soft capsule containing lutein 20 mg once a day for six months.
The subjects are to take a placebo soft capsule in the same shape once a day for six months.
Sponsors
Seirei Hamamatsu General Hospital
Dixon Laser Inst, Univ of Utah. Med Photonics Res Center, Hamamatsu Univ. Inflam Ophthalmol, Hokkaido Univ Grad School. Ophthalmol, Moran Eye Center, Univ of Utah.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Asian Patient who has hemilateral AMD and normal fellow eye or early ARM in the fellow eye. The normal or early ARM eye is to be assessed as the subject eye. Follow the definition of the precursory lesion presented in the diagnostic criteria) of the Japanese Ophthalmological Society when making the diagnosis of early ARM. More specifically, Diagnose the patient as having early ARM in the eye when having either of soft drusen (one or more drusen of not less than 63micrometer in diameter) or retinal pigment epithelial abnormalities (absence of the pigment, pigmentation, pigment unevenness, small (less than one papillary diameter) serous retinal pigment epithelial detachment). Patient of 50 years or over of age at consent, who is able to give written consent No visual acuity criteria. If the patient has corrected vision of 0.7 or under, the investigator needs to pay adequate attention for the presence or absence of the disease other than early ARM. No gender criteria Patient assessed eligible by the investigator based on the results of the screening tests Patient who has no allergy to lutein or zeaxanthin
Exclusion criteria
Exclusion criteria: Eye with cataract to the degree having substantial effects on the measurement of the macular pigment density. Exclude nuclear cataract of Grade 2 or severer nuclear sclerosis. The subject should be disqualified when having marked progression of cataract in the subject eye during the study period. The subject should be disqualified when undergoing the cataract surgery during the study period. Eye of which mydriatic pupil diameter is less than 6.5 mm Eye with glaucoma, diabetic retinopathy, or other serious disease Myopia of -6D or over Patient having as severe hepatic/renal impairment or cardiac disease as affecting the evaluation of the investigational supplement Patient continuously treated with any photo-sensitive drug (phenothiazine, chloroquine, tetracycline, etc.) Patient who constantly used lutein within 3 months Other subject assessed ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| macular pigment density | — |
Secondary
| Measure | Time frame |
|---|---|
| visual acuity, contrast sensitivity, glare sensitivity, plasma lutein level, OCT retinal thickness at the central fovea | — |
Countries
Japan
Contacts
Public ContactMasahiro Asano
Seirei Hamamatsu General Hospital General Clinical Research Center
Outcome results
None listed